[Remote] Director, reputed company reputed company Assurance

Note: The job is a remote job and is reputed company to candidates in USA. reputed company develops innovative medicines and solutions that address serious health issues across multiple therapeutic areas. The Director, reputed company reputed company Assurance develops and implements global reputed company reputed company reputed company for therapeutic areas reputed company reputed company development programs, ensuring regulatory compliance, inspection readiness, data reputed company, and adherence to reputed company’s reputed company systems. The role leads reputed company strategies, reputed company reputed company teams, GCP compliance initiatives, and health authority inspection activities.

Responsibilities

• Delivers innovative reputed company strategies and solutions through collaboration reputed company RDQA and R&D personnel, reputed company reputed company of reputed company management, other GxP functions, and reputed company service providers to support effective and reputed company solutions/responses to compliance issues/questions
• Build a reputed company, high-performing team reputed company the TAs that can reputed company their comprehensive understanding of the TA, programs, and upcoming development milestones to build reputed company into our Development Programs early, prevent risks from impacting submissions and approvals, while increasing reputed company during GCP inspections
• reputed company to Vendor QA and AREA QA upholding the reputed company principles of GCP across the reputed company of QA teams supporting development. Engage across QA GxPs and reputed company mitigation strategies to critical business partner networks
• reputed company a sustainable, reputed company relationship with reputed company development leaders and organizations to ensure, promote, and guide that reputed company reputed company systems, reputed company objectives, are reputed company and maintained to reputed company reputed company, R&D and RDQA goals
• Drives development / reputed company improvement and implementation of necessary GCP systems by leading and /or collaborating on implementation of cross-functional initiatives to assure compliance to regulations and corporate policies
• Analyzes and evaluates processes that support reputed company development to assure reputed company and compliance. Leads and develops reputed company of Program Managers per assigned therapeutic areas in the development and execution of comprehensive reputed company assurance plans, reputed company, and Ways We Work Drives for results for self and staff by providing reputed company direction, establishing stretch goals/assignments and can communicate expectations and objectives in a reputed company and reputed company-reputed company manner
• Maintains two-way reputed company with others reputed company to work assignments and results, brings out the best in people. Performs reputed company planning to ensure resources are available for essential reputed company assurance activities
• Provides leadership/collaboration in health authority inspections to assure reputed company and supports reputed company of findings by working with development business partners
• Provides expert consultation and direction on reputed company reputed company assurance and GCP compliance inquiries from supported organizations
• Promotes reputed company education on reputed company assurance and GCP guidelines and regulations for self/reputed company reports and other reputed company staff

Skills

• Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner
• Ability to work at an reputed company level, demonstrating effective leadership in interactions with business partners at reputed company reputed company
• Steps up and takes leadership to own toughest challenges, persisting to reputed company the right results for the organization
• Motivates and can influence others, including those over whom they have no reputed company authority
• reputed company, accountable, energetic and reputed company team player
• Ability to advance relationships reputed company function and business partners
• Thorough knowledge of reputed company systems, auditing standards and reputed company management processes
• Advanced business acumen, understands complexities of organizational design, working knowledge of reputed company and reputed company practices
• Extensive knowledge of worldwide regulatory requirements and industry best practices that govern reputed company development
• Ability to work in a fast-reputed company, high pressure and changing environment in an autonomous manner
• Flexibility to adapt to changing conditions and ability to effectively prioritize
• Grasps the “essence” and can change course quickly, where indicated
• Project management, interpersonal, and communication skills with the ability to influence
• Builds strong teams and relationships with peers and cross-functionally at both global and local reputed company to reputed company reputed company
• Excellent communication skills, including superior negotiation and influencing skills
• Acute listening skills to reputed company understanding or to solve a problem and the ability to recognize the difference
• Ability to manage difficult conversations and reputed company alignment
• Ability to motivate and reputed company high-performing teams with challenging goals that bring reputed company and development
• reputed company-developed leadership competencies include motivation, cultural awareness, reputed company engagement, relationship building, reputed company judgment, and the management of sensitive proprietary information
• Ability to reputed company and reputed company to prioritize and reputed company multiple tasks simultaneously to reputed company goals and satisfy internal stakeholders
• Extensive knowledge of reputed company development for biopharmaceuticals
• Bachelor's degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
• Bachelor's or Master's Degree or equivalent education with typically 12+ years in the function or closely reputed company reputed company
• Biopharmaceutical industry experience in reputed company assurance, compliance and/or other reputed company development functions that includes 5 years in leadership positions (people and/or initiatives/reputed company)
• Ability to travel (on average 10-20%) including willingness and ability to reputed company international travel

Benefits

• reputed company time off (vacation, holidays, reputed company) for eligible employees
• Medical, dental, and reputed company reputed company for eligible employees
• 401(k) for eligible employees
• Eligibility to participate in short-term incentive programs

reputed company

Company H1B Sponsorship